(25 days)
Not Found
No
The device description and intended use are for a standard guidewire, and there is no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The intended use states that the guidewires are used in percutaneous procedures to introduce and position other devices within the vasculature, which is a therapeutic procedure.
No
Explanation: The device, a guidewire, is explicitly stated to introduce and position catheters, pacing leads, and other interventional devices. This indicates an interventional or therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (stainless steel, nitinol, platinum wires, coatings) and physical characteristics (diameter, length, end shapes), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the guidewires are for "percutancous procedures to introduce and position catheters, pacing leads, and other interventional devices within the coronary and peripheral vasculature." This describes a device used within the body for medical procedures, not a device used to examine specimens outside the body to diagnose or monitor conditions.
- Device Description: The description details the physical characteristics and materials of a guidewire used in interventional procedures. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of diagnostic purposes based on laboratory analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This guidewire does not fit that description.
N/A
Intended Use / Indications for Use
These guidewires are intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.
Product codes
DQX
Device Description
The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, angled or with "J" end. The wires range from .014" diameter through .. 065" diameter and lengths from 20cm. to 360 cm. The wires are coated with a plastic hydrophilic or hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
DEC = 5 2003
LD33542
510(k) Summary of Safety and Effectiveness for Galt Medical's Hydrophilic Coated Vascular Guidewires (Prepared in accordance with 21 CFRPart 807.92) Date 11/18/03
- (1) Submitter: Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041 (972) 271-5177 Contact Person: David Catlin
- (2) Device Name: Guidewire Trade Name: Easy Pass Hydrophilic Coated Vascular Guidewire Classification Name: Wire, Guide, Catheter Classification Code: DQX
- (3) Substantial Equivalency: Galt Medical Corp. guidewires are substantially equivalent to guidewires from K982559, K021990, and K031916
- (4) Device Description: The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, angled or with "J" end. The wires range from .014" diameter through .. 065" diameter and lengths from 20cm. to 360 cm. The wires are coated with a plastic hydrophilic or hydrophilic coating.
These guidewires are intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.
- (5) Technological Characteristics: Galt Medical's guidewires have the same indications for use and are otherwise technically the same as the predicate devices.
- (6) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's hydrophilic coated vascular guidewires are considered substantially equivalent to the currently marketed predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 5 2003
Galt Medical Corporation c/o Mr. David G. Catlin Executive Vice President 2475 Merrit Drive Garland, TX 75041-6146
Re: K033542
Hydrophilic Coated Vascular Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: November 6, 2003 Received: November 10, 2003
Dear Mr. Catlin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. David G. Catlin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Alva D. Herz for
Bram D. Zuckerman. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 (k) Number (if known): ___ Lt 335542_
Device Name: Hydrophilic Coated Vascular guidewire
Indications For Use: These guidewires are intended for use in percutancous procedures to introduce and position catheters, pacing leads, and other interventional devices within the coronary and peripheral vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use,
(Per 21 CFR 801.109)
12/5/3
Prescription Use OR Over-the Counter Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number
(Optional Format 1-2-96)
12/5/3